Merck And Elsevier Exposed For Creating Fake Peer Review Journal
from the wow dept
I know I’ve mentioned for a while that I’ve been spending a lot of time looking into the healthcare industry — particularly pharmaceutical companies, but haven’t written that much about them yet because I haven’t had the time to put everything together. However, the one thing that seems pretty consistent is how incredibly untrustworthy some of these companies are. The claims that it costs $800 million to make a pill are totally unsubstantiated. The idea that patents are necessary to create drugs is also entirely unsubstantiated. The more you look at it, the more you realize that patents have actually allowed the pharma industry to slow down many potential life-saving innovations in favor of a drug-based solution that isn’t always the best. That isn’t to say that there aren’t some valuable pharmaceuticals, but the industry has a long history of deception and convincing the public and politicians that they need a lot more protection and money than they really do — and that their drugs are more effective than they really are.
Even so, I was still somewhat stunned to read (via Clay Shirky) that Merck supposedly created a fake peer-reviewed journal to publish data that made its drugs look good. It also got Elsevier to publish the journal to make it look legit (Elsevier being one of the bigger publishers of — of course — proprietary medical journals). Two companies with a history of locking up information and data teaming up to mislead doctors and the public? What a shock…
Of course, this is exactly the sort of thing that you can do when everything is locked up and proprietary, rather than open. There’s almost no way to confirm or check the data or information to make sure it’s legit, so people tend to assume it is. In that regard, perhaps it’s no surprise that the two companies eventually went down this road, but it does highlight one of the problems with the way the system works today. As Shirky later points out this is hardly unique for a firm like Elsevier, which has faced some serious ethical questions regarding its publications in the past as well.
Filed Under: closed source, journals, peer review, pharmaceuticals, proprietary, scams
Companies: elsevier, merck, reed elsevier
Comments on “Merck And Elsevier Exposed For Creating Fake Peer Review Journal”
Think about it, why are these corporations fabricating data? In order to sell their patented products. It’s the patents that substantially increases the incentive to fabricate data because patents allow one to sell a product way above cost. If one fabricates the data of an unpatented product to the benefit of the product everyone else will start selling the product and hence it won’t substantially help those who fabricated the data.
?
What do you expect out of Merck? This is the Rockefeller company that partnered w/a Nazi company (Schering AG), then, through the Rockefeller Foundation, proceeded to single handedly determine medical educational policy and public health policy through the NIH. Then Rumsfeld releases Aspartame in every diet soda in the world by appointing the FDA chief who pushes its approval through despite it being opposed by the panel.
Yay, corporatocracy!!!
Re: ?
See, now everyone’s having fun!
hmmm
shady drug dealers – thats a new take on things
Re: hmmm
Why would they NOT want to protect this scheme with a FAKE Peer Review? They would have to be idiots.
Legalized Drug Dealers with $1500 suit and ties, public stocks, pretty cars, and even fancy lawyers to protect them from going to jail due to their greedy ways.
For more on how patents cause corruption read http://forums.christianity.com/m_3795161/mpage_1/tm.htm (post 11). I think the patent system is also potentially dangerous to the environment. It gives corporations incentive to manipulate data into saying that patented products are better for the environment than they really are (ie: Freeon was banned only AFTER the patent expired and it was replaced by another patented product) and to say that products that aren’t patented are worse for the environment than they really are. If we want to know the true effects of a product on the environment then we don’t need the incentive that our patent system creates to skew the data into favoring patented products over non – patented products (which creates incentive to distort the data). Again, back to why the patent system is the cause of all this corruption goes back to basic economics. Whenever you have a monopoly the monopoly wastes resources in order to maintain itself (ie: to manipulate government and act corrupt) and the patent system gives corporations incentive to act corrupt and waste resources maintaining the profits from their patented products (even if that means skewing important data and hiding important data).
Old drug...meet the new drug
How many of these drugs get FDA approval for sale, go infomercial sales for a year only to have the FDA revoke the approval? Then 6 months later every ambulance chasing lawyer wants you to call them so they can help you claim the money you are “entitled” to. Then a ‘new’ drug comes out that supposedly does the same thing (maybe they change the chemical makup of some inconsequential molecules) and the cycle repeats. I wouldn’t doubt that the lawyers are in on it, too. A nice little love triangle. Whoa…what a rant!
You may also read my comments under why patents cause more harm than good for more details. http://www.techdirt.com/articles/20080318/004156568.shtml
For potential solutions (and the true reason why solutions won’t be implemented) see my comments under
http://www.techdirt.com/articles/20090414/1826114514.shtml
http://www.techdirt.com/articles/20090426/1855224648.shtml
http://www.techdirt.com/articles/20090417/1923324548.shtml
and
http://www.techdirt.com/articles/20090414/0248514500.shtml
...
Like Chris Rock said… ain’t no money in the cure, the money’s in the treatment
Anonymous Coward, you must realize that it is our patent system that causes this corruption. You hardly see this level of corruption with generic drugs, fabricated data just means your competitors will be helped as much as you and hence everyone still earns a normal profit.
I used to work for a US subsidiary of Elseiver. They were in the business of locking up construction data and reselling it. Never saw anything more shady than the usual bad management…
“I know I’ve mentioned for a while that I’ve been spending a lot of time looking into the healthcare industry — particularly pharmaceutical companies, but haven’t written that much about them yet because I haven’t had the time to put everything together.”
Read my stuff here
http://forums.christianity.com/The_FDA_and_health/m_3795161/mpage_1/tm.htm#1
and here
http://forums.christianity.com/Red_Yeast_Rice_and_the_FDA/m_3777330/mpage_1/tm.htm#1
It’s long and it’s a lot of information but it also ties in how patents cause so much of the corruption within the pharmaceutical industry (and how pharmaceutical industries benefit from publicly funded research by getting exclusive patents on products that emerged partly as a result of research done with tax dollars).
While this rather transparent attempt obviously points toward egregious dishonesty and lack of ethics, a close read of the journal wouldn’t and shouldn’t have fooled any self-respecting doctor or other health professional into believing it was a peer-reviewed periodical.
However, since lay-persons aren’t necessarily as focused on the difference between peer-reviewed journals and pay-to-publish journals, these actions are even more despicable.
Moreover, this shouldn’t be seen as out of the ordinary. There are other examples of this. For example, many medical specialty societies sponsor journals and not all of them are peer-reviewed, yet to the lay-person, they may all seem to be the same.
Unsubstantiated?
The idea that patents are necessary to create drugs is also entirely unsubstantiated.
Mike, there have been several studies that examine the relative value of patents to the innovation process. Edwing Mansfield in the 1986 paper “Patents and Innovation: An Empirical Study,” (http://www.lu.se/upload/CIRCLE/INN005/Mansfield_Patents_and_Innovation.pdf), claims that 60 percent of all pharmaceuticals would not have been developed without patents and 65 percent would not have been introduced without patents.
It is easy to claim that this study is biased, but note that about half of the twelve industries studied show little or no benefit to patents, which one would expect in some industries.
The data was collected through detailed interviews and correspondence, which always leads to the chance for bias. However, if there was a general propensity to bias toward patents, the percentages should have been higher across the board rather than relatively low in all industries except for pharmaceuticals.
This study was based on a random sample of firms and updates a study performed by Mansfield, Schwartz and Wagner in 1981. The 1981 study found that 90% of pharmaceutical innovations would not have been introduced without patents. The 1981 study also found that 20% of chemical, electronic and machinery innovations would not have been introduced without patents, which seems much more consistent with the 1981 study than the pharmaceutical numbers.
As a separate, but related issue, Albert G.Z. Hu and I.P.L. Png in their paper “Patent Rights and Economic Growth: Cross-Country Evidence,” found a strongly positive correlation to economic growth and total factor productivity growth. This 2009 paper appears to be somewhat contrary to the earlier paper by Boldrin and Levine, who found no correlation between the strength of patents and TFP.
There are an array of other papers that have tied the patents to positive economic benefits. Some have problems, but those problems in some cases have been addressed by other papers. What is more humorous is when these papers are completely ignored or waived off by a “they are biased” or “they neglect to consider…” arguments. The proper response to a paper that provides a supported conclusion is to provide superior data and a superior conclusion, not dismissal because you dislike the supported conclusion.
Off my soapbox now.
Re: Unsubstantiated?
Even if they are or they do. We shouldn’t let little things like that bother us, now should we?
Re: Re: Unsubstantiated?
We should let things like that bother us when they are mere conjecture and are unsubstantiated.
“What is more humorous is when these papers are completely ignored or waived off by a “they are biased” or “they neglect to consider…” arguments.”
Oh yeah, because anything that refutes your presumption must be wrong a prior and hence counter arguments and refutations don’t count.
Re: Re:
Actually, any substantiated counter argument or refutation would be welcomed. I am busy reading yours.
errr…. a priori
Generic drug makers don’t “fudge” their data because they have no data to fudge.
I doubt that patents have much to do with this “fudging” of data, were there no patents, companies would still be doing this.
It would reduce the incentive for companies to fabricate data. Not to mention patents give incentive to suppress studies on generics and the publication of positive results. I don’t buy the nonsense that funding would otherwise be impossible either, Nasa (and universities) spends a lot of money on figuring out the orientation of various galaxies and that hardly helps us out (or has any other economic benefit). Certainly money can be otherwise raised for studies on generic drugs. After all, pharmaceutical industries spend more on marketing and advertising than research and development and much of the research and development for drugs (and herbs, etc…) is publicly funded and conducted by universities. It’s just that patents create a huge incentive to suppress studies and positive publicans of unpatented products.
“Generic drug makers don’t “fudge” their data because they have no data to fudge.”
They don’t fudge data because they have much less incentive to fudge data. Patented drug makers have data but most of it is fudged (and they cherry pick data) because positive results don’t really help competitors.
Studies on generics? Generics are same chemical compound as the label drug. There is really no need for studies on generic drugs. If there is a generic substitute for the label drug, people should take it.
Telecom companies don’t “fudge” their data? Food companies don’t “fudge” their data?
err. sp/publicans/publications
“Telecom companies don’t “fudge” their data? Food companies don’t “fudge” their data?”
Actually, in the case of food companies, they didn’t until patents started getting involved. Look at monsanto (and how they fudge genetically modified organisms because they are patented). Here is a recent example.
http://www.huffingtonpost.com/jeffrey-smith/monsanto-forced-fox-tv-to_b_186428.html
The patent system is behind it. Before this many studies could be found (ie: conducted by universities) telling us about the benefits of eating fruits and vegetables. No patents on fruits and vegetables are required for studies to be conducted.
[quote]
Studies on generics? Generics are same chemical compound as the label drug. There is really no need for studies on generic drugs.
[/quote]
This is like saying that because bananas all have the same chemical compound there is no need to study how they effect health. This is a ridiculous argument. Just because two products are identical doesn’t mean that there is no need to study them. People study identical twins, just because they are identical doesn’t mean there is no need to study them.
Re: Re:
I think you missed the point of the original post. The author’s point was that generic manufacturers do not study generic drugs. The drugs are approved on the basis of studies conducted by the original producer/inventor. The drug is assumed to have been proven by the time generics produce them. Indeed, generics in general have no capability to research drugs.
Lets just label all stars identical and stop studying them. In fact, if there are two identical objects, lets not study any of them.
(the above example doesn’t have to do with genetically modified products in particular, it was just a general example of how, once patents get involved, so does fabrication of data).
[quote]
“Telecom companies don’t “fudge” their data? Food companies don’t “fudge” their data?”
[/quote]
Exactly, to the extent that patents aren’t involved, data isn’t fudged (as much). Thanks for making my case for me.
I hate doing this but...
I try so hard to avoid being the naive idealist, because it is a tendency that I find so off-putting in others. But I’ve always found Big Pharma to be the soft spot that makes me give up on the market, profits and other realistic considerations and say:
To hell with this. We are talking about the field of science that is among our only hopes to sustain the number of people we have on this planet. Responsible pharmaceutical research is essential to human life as a whole going forward. How can it be fixed? I don’t care. Socialize the whole damn thing. Centralize it globally. Shut down all the companies who refuse to let generic drugmakers treat AIDS for pennies in Africa. Shut down the companies that send free one-week trials of Prozac to sixteen year old kids in the mail. Take them to court for crimes against humanity.
These are not notions that would even enter my mind normally but they start to look like the only options in this world where half of our medical knowledge is owned by corporations. I laugh when people here in Canada talk about our public health care – I’m glad I can see a doctor for free, but it’s so hard for me to think of it as “public” when the treatment for the vast majority of ailments is “go buy these pills from a private manufacturer through a private chain of drug stores”
If you believe that generics need to be studied (under clinical trials) then you really don’t understand how the generic industry works.
Generic manufacturers do not run their products through clinical trials. One of the major reasons they are cheaper is because they do not undergo clinical trials. There is also no R done on them either.
[quote]
If you believe that generics need to be studied (under clinical trials) then you really don’t understand how the generic industry works.
[/quote]
There is no reason not to study them. Perhaps a particular generic company may not, but another may. Or a university (as most patented products are often partly a result of university funding anyway).
Take DCA. http://www.uncommondescent.com/off-topic/dca-update-big-pharmaglacial-rate-of-progress/
(read post 2)
Researchers at a university found that DCA could help cure cancer. DCA was a generic (but it wasn’t used for cancer) and after the researchers found this out, the FDA banned it for this purpose (probably because they didn’t want it to compete with patented products). The point here is that studies can be done on generics without patents and things can be found out about them. After all, it’s common practice for doctors to prescribe a generic drug meant for one thing for a completely different purpose. These generics can be studies for other purposes as well. Just because something is a generic is no reason not to study it.
Re: Re:
You are STILL missing the point. Take a generic drug, say the generic version of Lomotil. Generic manufacturers are NOT studying whether Lomotil is effective. Generic manufacturers are NOT studying whether Lomotil is effective in curing baldness. Generic manufacturers are not studying their drugs at all (there may be exceptions to this, but in general generic manufacturers do not have R&D divisions that develop drugs). Others may be studying generic drugs for other purposes, but that has nothing to do with the original purpose for the drug and also has NOTHING to do with patents.
Re: Re:
roflmao…DCA is the subject of several patent applications, but apparently the FDA has concerns about safety. So, since DCA for the treatment of cancer has patent applications filed, and yet the FDA has banned the use for the treatment of cancer, how does that fit with your little conspiracy mind?
Citations
I don’t like to sling unfounded accusations. I dug up a mirror of the AP story about the 16-year-old on an advocacy website:
http://www.namiscc.org/News/2002/Summer/ProzacMailing.htm
I’d prefer link directly to AP of course, but they won’t even give me a link to the STUB of the story from the search page – it just sends me straight to the pay page. What a useless website.
[quote]
Generic manufacturers do not run their products through clinical trials. One of the major reasons they are cheaper is because they do not undergo clinical trials. There is also no R done on them either.
[/quote]
Some of that reason fewer studies are done on them could be because they have been around for a while and hence the studies have already been done. That’s not to say that patents are required for research to get done.
Re: Re:
I sure wish I know what you meant by your comment.
I found this from the article.
“S.K.’s sample Prozac was an attempt by Lilly to switch patients to a new variety of the brand-name drug because the patent for Prozac taken daily had expired, Farmer said. The drug now is available in a cheaper, generic copy.”
http://www.namiscc.org/News/2002/Summer/ProzacMailing.htm
More examples of how our patent system causes more harm than good. Of course these corporations will probably lobby the FDA to try and ban the unpatented variant of Prozac in order to force people to buy the patented version.
Of course this doesn’t mean that the patented version is any better (or safer) than the unpatented version, just that the patented version makes these corporations more profits.
Nevermind, it wasn’t regarding a patent variant of Prozac. Then again, LSD was banned only after the patent expired, so now that the patent for prozac has expired there is an increased chance that it will eventually be banned (because it competes with other products).
Re: LSD
Regarding LSD, I think you are a little misinformed. LSD was patented in 1948 in the United Stated. The patent expired in 1953, presumably because a maintenance fee was not paid. It is likely that the patent was allowed to expire because the use of LSD to treat any diseases or conditions was minimal.
The FDA passed stringent regulations on the use of LSD in 1962, which is also the same year the first arrests for possession of LSD occurred, nine years after the patent expired. Twelve years after the patent expired, possession of LSD was banned by Congress.
When a decade passes after the expiration of a patent before use is banned it hardly seems like there is either correlation or causation. Indeed, sounds like a conspiracy theory.
Since 2006, there has been a move to loosen the restriction on the possession and use of LSD as there are studies that show LSD has beneficial effects on the treatment of several conditions.
Re: Re: LSD
“LSD has beneficial effects on the treatment of several conditions.”
as any kid who grew up in the suburbs can tell ya, its a great cure for boredom.
“I think you missed the point of the original post.”
I did not miss the point, I got the point. My point is that just because something is generic doesn’t mean that we have to stop studying it and that patents aren’t required for things to be studied. The reason the generics aren’t studied as much is because they were already studied in the past, not strictly because they are not patented. We can study the sun, no one needs a patent to study the sun. At the same time, once we have studied something long enough we eventually stop studying it (for that particular thing that we already know) not because there is no patent, but because it’s already been studied.
Re: Re:
Okay…so what is your point?
In response to your other comment regarding switching patients to other drugs, that comment may be accurate, but how is that different from any other business? When you go to buy a car, do they try to sell you the more expensive version or more expensive options? Of course they do. EVERY BUSINESS DOES THIS WITHOUT EXCEPTION. Even when you go to a fast food restaurant they try to encourage you to add items or to upgrade the size. So, your comment means that pharmaceutical companies behave like virtually all other companies? What a shock.
[quote]
I sure wish I know what you meant by your comment.
[/quote]
I’m not used to debating on these forums because you can’t edit things. I make typos and re – read through them but by the time I post something it’s too late. I apologize, I just have to get more used to this form of debate I suppose.
So to say that patents are required for new drugs to be studied is ridiculous. We, as a society, can do research on things without patents.
Re: Studying Drugs
Of course we do not need patents to study drugs. I fail to recall anyone EVER having said that (if they did, they were wrong). What a number of people HAVE said is that a patent secures the ability to restrict others from producing a drug for a period of time to permit the original inventor time to recoup the significant cost of developing the drug.
“Regarding LSD, I think you are a little misinformed.” I am not misinformed, I know the history. It was allowed for the time being that it was patented and they knew just about everything that they knew about it after it was banned before the patent expired (ie: hallucinations, etc…).
Re: LSD
So, how do you explain that the ban did not occur until a decade after the patent expired?
“What a number of people HAVE said is that a patent secures the ability to restrict others from producing a drug for a period of time to permit the original inventor time to recoup the significant cost of developing the drug.”
Most of which comes from universities (tax dollars) anyway. After all, drug companies spend more on marketing and advertising than they do on research and development. So why don’t taxpayers get to recoup their costs? Why do private entities get exclusive patents on products that universities helped fund studies for.
Re: Spending
Would you care to cite a specific study that shows that “most” of the money for patented drugs come from tax dollars?
“So, how do you explain that the ban did not occur until a decade after the patent expired?”
A decade is not that long.
Re: A decade is a long time...
The reason it took a decade to ban LSD is that it took the drug a decade to become abused and to cause significant health problems. Had the drug continued to be an obscure drug for the 13 years it took to be banned, it probably would never have come to the attention of Congress. If someone banned it purely because it was no longer patented, the ban should have happened within years, not nearly a decade and a half later.
Drugs are expensive, say the pharmaceutical companies, because of the years of research and failed trials that go into making a successful drug. However, they neglect to mention that up to 50% of the research and development cost in the world is incurred by the public sector. Tremendous amounts of drug research is funded by university funding and government grants.
“But when putting a figure to the R&D costs, pharmaceutical companies include these public sector costs as if they were their own. This inflates the stated expenditure associated with R&D per drug for a company and provides an artificial justification for extremely high prices. To burst another drug company bubble, I should include that these companies spend more on marketing and administration than on R&D. It basically goes without saying that the pharmaceutical industry has been one of the most profitable industries in the nation for several years straight. “
http://www-tech.mit.edu/V123/N41/shef_colum.41c.html
Here are the studies
http://articles.mercola.com/sites/articles/archive/2001/08/15/drug-war.aspx
“The Tufts study also dramatically illustrates the significance of the point at which a company acquires the technology. Government-funded medical R&D typically focuses on the early stages of a drug’s development, when the risks are the highest.
For many drugs, the government has paid for most or all of the pre-clinical research, and it frequently funds the development of the drug all the way through FDA Phase II and Phase III trials. In these cases, which are many, the drug should not be priced as though the firm had borne all the risks and made all the investments.”
Again, we don’t need patents to develop new drugs.
Re: Patents & Drugs
Two problems with your comments.
First, you seem to be saying that part of the problem with drug research is that drug companies are ripping off the American people by charging high prices for drugs developed by the government. I must disagree. The very article you pointed to clearly states that it was the GOVERNMENT that gave the monopoly for Taxol to Bristol-Myers Squibb. Is that Bristol-Myers Squibb’s fault for taking advantage of what appears to be an inappropriate action by our government? I have to blame our government for providing a monopoly when they should not have.
Second, regarding your comment about needing patents to develop new drugs, that is partially correct and partially not. New drugs are developed without patents. However, as noted in the study I provided earlier, an estimated 60% of new drugs would not have been developed without patents and an estimated 65% of new drugs would not have been produced without patents. Your link to Dr. Mercola does not say otherwise.
“That is, the drugs that were developed with government funding were 3 times as expensive as the drugs developed without government funding. In 1991, the most recent year of the study, drugs developed with federal funding were over 11 times more expensive than drugs developed without federal funding.”
…
“For many drugs, the government has paid for most or all of the pre-clinical research, and it frequently funds the development of the drug all the way through FDA Phase II and Phase III trials. In these cases, which are many, the drug should not be priced as though the firm had borne all the risks and made all the investments.”
…
The Orphan Drug Act has vastly increased the monopoly pricing power for many drugs, and it has created special challenges for drugs developed with public funds. The first firm to obtain FDA approval to market a drug that can qualify as an orphan is automatically granted marketing exclusivity, regardless of the company’s role in the drug’s development.
Elsevier not to be trusted
Having had the opportunity to work with Elsevier for years, I’ve chosen not to…..that should tell you something. Not only are they unethical, but their managers are cruel to their employees, the work load is unacceptable, and the pay is bad also. Perhaps the Dutch-based firm is ‘smoking’ too much and their judgement is impaired LOL.
“The reason it took a decade to ban LSD is that it took the drug a decade to become abused and to cause significant health problems.”
What health problems? Virtually no one has died of chemical intoxicity of the drug (most of it was behavioral intoxicity and that was known before the patent expired). A simple wikipedia search can tell you this, this is common knowledge. Now you’re just making things up.
Re: Re:
http://www.drugs.com/lsd.html
http://www.sigep.org/documents/lsd-fact-sheet.pdf
Now I am just not making things up.
“If someone banned it purely because it was no longer patented, the ban should have happened within years, not nearly a decade and a half later.”
That’s nonsense, I don’t expect the government to constantly make it that obvious.
Even wikipedia tells you that the chemical toxicity level of LSD is VERY low. Again, you are just making things up.
Re: Side Effects from LSD
Still not making things up…
http://www.drugs.com/lsd.html
http://www.sigep.org/documents/lsd-fact-sheet.pdf
Re: Re:
Even wikipedia tells you that the chemical toxicity level of LSD is VERY low. Again, you are just making things up.
Right, because if it’s on Wikipedia, it has to be true. :rolleyes:
So I guess it should be obvious by now that patents aren’t required to find funding for new drugs. Not to mention patents give more incentive for corporations to lie about their funding (to try and justify their patents). So why should I believe they tell us the truth?
“First, you seem to be saying that part of the problem with drug research is that drug companies are ripping off the American people by charging high prices for drugs developed by the government. I must disagree. The very article you pointed to clearly states that it was the GOVERNMENT that gave the monopoly for Taxol to Bristol-Myers Squibb. Is that Bristol-Myers Squibb’s fault for taking advantage of what appears to be an inappropriate action by our government? I have to blame our government for providing a monopoly when they should not have.”
If we don’t have patents, we don’t have to worry about these corporations influencing the government into doing such actions and we don’t have to worry about the government granting patents for projects that are federally funded. The patent system creates more burden in trying to eliminate this corruption.
Re: *Sigh*
The web site you pointed to did not indicate that any drug company influenced the government into granting one company a monopoly before hand. You are making stuff up.
As for the patent system, the patent system burden you are discussing appears to be an irrelevant, separate issue for which you have provided no evidence. You are missing standard government incompetence with other issues, which means you are making stuff up.
Re: Missed Nothing
You are missing the point that 60% or more of all drugs would not exist without patents. Are we better off with those drugs or without? Patents CLEARLY provide more drugs than would be obtained without drugs, unless you have evidence that says otherwise.
Let us say this slowly and clearly:
Patent protection has provided about 2/3 more drugs than would have been provided without patent protection. While patent protection is unnecessary to develop new drugs in general, the vast majority of new drugs have been developed because patent protection exists.
Re: Patents & Taxol
Actually, the government did not need patents to give Taxol to Bristol-Myers Squibb. All the government had to do was approve Bristol-Myers Squibb as the only FDA approved supplier of Taxol, and everyone else would be denied the right to supply Taxol. Patents were merely an avenue to a government end that still makes no sense to me.
You are somehow associating patents with this abuse of government power. Because cars kill people, should be ban cars? Because ATM’s only give money to people who have ATM cards and an account, should we eliminate them as well? You have suggested causation without evidence that lack of a patent system would have changed anything.
and again, you still miss the point. The point is that patents aren’t needed to fund research into new drugs.
“The web site you pointed to did not indicate that any drug company influenced the government into granting one company a monopoly before hand. You are making stuff up.”
I never said it did, but to say that these corporations have no influence on government is nonsense. Patents create an incentive for them to manipulate the government.
Re: Conjecture
So, you made that part up. Since the possibility exists, it must be reality?
Re: Patents & Government Influence
You made that up. Please. Have you any better story than this? Let me think here. Defense companies may get patents, but they are not permitted to charge any more for their military products than the government allows. Military companies have been trying to influence the government for years, and patents are not part if it. So your suggested causation is proven false.
Public works companies have been trying to influence the government, frequently successfully, for years, and not one patent is involved. Once again, your suggested causation is proven false.
You have hypothesized that the existence of patents causing companies to influence the government. I have never seen a study that suggests that this statement is supported.
“You are missing the point that 60% or more of all drugs would not exist without patents. Are we better off with those drugs or without? Patents CLEARLY provide more drugs than would be obtained without drugs, unless you have evidence that says otherwise.”
Many of which are simply me too drugs and do not work better than their previous generics.
Re: Me too and do not work...
Unsubstantiated statement that you made up on the spot.
I take a “me-too” drug called Zetia that does not have the side effects of the drug that it “me-too’s” from. Many so-called “me-too” drugs react differently from other drugs and thus provide benefits for millions of people who could not take other chemical configurations.
“You are missing standard government incompetence with other issues, which means you are making stuff up.”
Again, with no patents, one doesn’t have to worry about the government acting with such incompetence as to give people patents on federally funded products.
Re: Re:
You made that up. Please. Have you any better story than this? Let me think here. Defense companies may get patents, but they are not permitted to charge any more for their military products than the government allows. Military companies have been trying to influence the government for years, and patents are not part if it. So your suggested causation is proven false.
Public works companies have been trying to influence the government, frequently successfully, for years, and not one patent is involved. Once again, your suggested causation is proven false.
You have hypothesized that the existence of patents causing companies to influence the government. I have never seen a study that suggests that this statement is supported.
No, it is true that patents create more incentive to manipulate the government into such actions. This is basic economics.
Re: Re:
Show me a proof. Show me a study. Show me something other than your baseless accusation.
and if you seriously trust the government, and these corporations, not to do such a thing, I must say you are naive. Because we all know how honest the government and big corporations are.
I take a “me-too” drug called Zetia that does not have the side effects of the drug that it “me-too’s” from. Many so-called “me-too” drugs react differently from other drugs and thus provide benefits for millions of people who could not take other chemical configurations.
Again, most of the funding comes from taxpayers which just shows that if the drug is to pose some real benefit we don’t need patents to fund it.
Re: Your links dispute and disprove this...
Your link to Doctor whats-his-name says that the government pays for 42% of medical research, which includes drugs. Now, my math is a little rusty, but 42% seems like a lot less than “most.”
Next, we move on to what portion of that 42% is spent on drugs. I have seen a wild array of numbers that go from all of it (which is totally absurd because the government pays a good percentage for basic research), to a small fraction.
Using my own fudge factor (i.e., I admit that I am making this up, as opposed to your completely unsupported assertions), considering the numerous non-drug related government reports, I am guessing that perhaps 20 to 30% of that amount goes to “drug research,” however that is defined. That would mean that the government pays for about 8% to 12% of drug research, which is REALLY FAR AWAY FROM EVEN BEING SIGNIFICANT. Do you have any better information?
Re: Re:
You have yet to prove that “most of the funding comes from taxpayers.” The single source you cited has evidence that most of the funding DOES NOT come from taxpayers. Are you able to keep your lies straight?
“You are missing the point that 60% or more of all drugs would not exist without patents. Are we better off with those drugs or without? Patents CLEARLY provide more drugs than would be obtained without drugs, unless you have evidence that says otherwise.”
So the pharmaceutical corporations make the government pay for most of the research and development and the pharmaceutical corporations get the patent. The fact that taxpayers can pay for the R&D is evidence that funding does not have to come from patents.
Re: Re:
You have yet to prove that “most of the funding comes from taxpayers.” The single source you cited has evidence that most of the funding DOES NOT come from taxpayers. Are you able to keep your lies straight?
None of your links provide evidence that LSD was banned for reasons unknown before the patent expired. Read wikipedia on this, it’s well known that LSD has very low chemical toxicity. Any drug, if abused, can be bad for you (generics and patented, even too much water), the solution is to keep the drug away from abusers, not to ban it. They only banned it after the patent expired.
Patents & Drugs
Just look at insulin it has been around along time but is not on a generic list and is always on the the high end of insurance co-pays. And if you lose your Job and healthcare coverage like i did you are raked over the coals just trying to pay for it. With insulin being around as long as it has why is there no generic offering?
the drug companies have a tight grip on it and the patents and will not let any one get in the way of their cash cow.
with having to deal with diabetes ,congestive heart failure and cancer with my wife over the last 3 years and all the drugs she takes its impossible to pay for them with no health care coverage.
Re: Patents & Drugs
Except one detail Linuxjoe, patents have NOTHING to do with the reason that insulin is not generic. Nothing. Ineed, Congress in 2007 pressed the FDA for approval of generics since the patents on some variations of insulin had already expired. As I noted in another post, the government does not need patents to keep other companies from making drugs, they just have the FDA keep from issuing approval to make the generic – which is the case here.
Costs of developing new drugs
The claims that it costs $800 million to make a pill are totally unsubstantiated.
Joseph A. DiMasi, Ronald W. Hansen and Henry G. Grabowski, The Price of Innovation: New Estimates of Drug Development Costs, 22 J. HEALTH ECON. 151 (2003)
Is that enough substantiation for you?
Re: Costs of developing new drugs
Is that enough substantiation for you?
Uh, not at all.
The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms
They surveyed the companies for their own data, and those firms gave data that substantiated their bogus claims… If you actually looked at the details, as Merrill Goozner did, you find that the pharmas count all sorts of stuff towards the dev of drugs that aren’t accurate. Sometimes that includes marketing costs. Sometimes it includes totally made up costs. Sometimes it includes the “cost” of research that is done at a public laboratory that has nothing to do with the pharma whatsoever.
The actual costs, in Goozner’s research? More like $30 to $40 million.
And I won’t even get into the 11% discount rate.
“Right, because if it’s on Wikipedia, it has to be true. :rolleyes:”
You’ve provided no evidence to the contrary (just speculation).
Re: Re:
You’ve provided no evidence to the contrary (just speculation).
You’re right, I haven’t. The poster before me did.
http://www.techdirt.com/article.php?sid=20090503/1255574725&threaded=true#c788
“Your link to Doctor whats-his-name says that the government pays for 42% of medical research, which includes drugs. Now, my math is a little rusty, but 42% seems like a lot less than “most.””
You seemed to have overlooked the parts that I quoted.
“For many drugs, the government has paid for most or all of the pre-clinical research, and it frequently funds the development of the drug all the way through FDA Phase II and Phase III trials. In these cases, which are many, the drug should not be priced as though the firm had borne all the risks and made all the investments.”
“Do you have any better information?”
The information that I provided you is fine. You’re the one who refers to industry studies that are potentially skewed by conflicts of interest (because our patent system gives incentive to skew data). Because we all know how honest industry is.
Re: Exaggeration
Look, the study clearly says that the government funds 42% of medical research. The study also clearly says that drug research is a PART of that 42%. Your study says that “many drugs” have had “most or all” of the pre-clinical research paid for by the government. Okay, is many 5 drugs? Is it 10 drugs? HOW MANY is MANY? You have nothing but unsupport conjecture that it is MOST. The article you cited DOES NOT SAY THAT. In fact, since I suggest that you and doctor whats-his-name are just as skewed because you have a hidden agenda you are not sharing.
Provide evidence or leave me alone.
Someone even has a patent on swinging sideways. http://www.newscientist.com/article/dn2178-boy-takes-swing-at-us-patents.html. So many other patents are absolutely ridiculous yet people like you would try and defend them like they are reasonable. Yeah right.
Re: Re:
What does that have to do with the price of drugs? You are trying to derail the conversation. This statement does nothing to prove your point. In fact, it makes me suspicious that your are deliberately trying to be obtuse.
I don’t know what happened to the link (it doesn’t seem to work) but here is an example of how conflicts of interest cause the distortion of data.
[quote]
…the gold standard of consumer protection: Before any pharmacist can hand over an orange bottle, the FDA must study the data on that drug and approve it.
But a recent report by The Oncologist medical journal has exposed how flimsy that standard really is. The article’s authors counted the number of drug company clinical trials that get published — versus how many trials the companies actually conduct. The answer: only a tiny fraction.
…
The pattern these registrations show is shocking. Commercial drug companies published fewer than six percent of all the clinical studies they undertook to test their drugs. [/quote]
http://www.chron.com/disp/story.mpl/editorial/6285963.html
(I posted this on http://forums.christianity.com/m_3795161/mpage_5/printable.htm when the above link worked).
Many of these studies are skewed (and data is buried) and it is our patent system that gives the incentive to skew and bury important data. So why should I trust the integrity of your industry studies that claim that patents are good, especially when the patent system itself creates a huge incentive to skew such studies.
Re: Re:
You sound like a broken record. You have yet to provide one, single, solitary piece of evidence that shows causation between patents and the incentive to skew studies. In fact, I believe you are the first person I have ever seen that people skew medical studies because of patents.
Enough of your nonsense. Go back to Roswell and the convention.
Unfortunately, I can’t find more info about that study. The only other thing I can find is this (I wish the website didn’t get deleted).
“UTMB’s Dr. Howard Brody is quoted in this editorial about the number of clinical trials conducted for a new drug versus the number of studies that are published. Commercial drug companies published fewer than six percent of all the clinical studies they undertook to test their drugs. “If a drug works, [the drug companies] have no incentive to suppress the data,” Brody said.”
http://blog.utmb.edu/newsroom/?p=4583
I will keep looking for more info on this. Maybe someone else can lead me to more info or the publication.
Re: Re:
And this information proves the link between patents and skewing data how…?
One thing that people assume is that only the drug industry “fudges” data. There are numerous cases where a academic researcher fudges data not because of patents but because of the rush to publish first. Their data has nothing to do with patents yet they still do it. Look at the case of the Korean academic that did it with stem cell research.
Academic research (devoid of patent interests) are probably as susceptible if not more than drug research.
How do you explain that?
Health care as a share of U.S. gross domestic product has tripled from 5 percent in 1960 to 16 percent today. Some analyses project the number will reach 25 percent by 2030. But this inflation is not due to spending on drugs. In a 2002 study for the National Bureau of Economic Research, the Columbia University economist Frank Lichtenberg estimated that, on average, “reducing the mean age of drugs used to treat a condition from 15 years to 5.5 years…increases prescription drug spending by $18 [averaged over the total population] but reduces other medical spending by $129, yielding a $111 net reduction in total health spending. Most of the savings are due to reductions in hospital expenditure ($80) and in physician office-visit expenditures ($24).” In other words, using newer drugs reduces other medical expenditures by more than seven times the extra amount spent on drugs.
As for “me-too” drugs, the implication is that companies are trying to take market share from each other without providing any “real” benefits to patients. Of course, “trying to take market share away” is better known as “competition,” which ultimately results in lower prices.
First some write that patents are bad because it doesn’t provide competition, then they write that “me-too” drugs are bad. Which one is it?
“The Taxpayer Assets Project also studied the funding of all cancer drugs that were discovered since the National Cancer Institute’s (NCI) new drug program began in 1955 and approved for marketing by the FDA through 1992. Of the 37 cancer drugs, 92 percent, or 34 cancer drugs, were developed with federal funding.”
The Taxpayer Assets Project also studied the funding of all cancer drugs that were discovered since the National Cancer Institute’s (NCI) new drug program began in 1955 and approved for marketing by the FDA through 1992. Of the 37 cancer drugs, 92 percent, or 34 cancer drugs, were developed with federal funding.
You didn’t read the article.
Another article about this.
“It seems as though pharmaceutical giant Merck (best known for the deadly painkiller Vioxx), has teamed up with science publishing titan Elsevier (who, not long ago, got caught producing a rather questionable math journal) to put out a fake peer-reviewed medical journal.”
A questionable math journal? Researchers became concerned when it was stated that 2 plus 2 actually equals 26.
“Provide evidence or leave me alone.”
Evidence was already provided, you just choose to ignore it.
“There are numerous cases where a academic researcher fudges data not because of patents but because of the rush to publish first.”
I never said that data isn’t tampered with in other contexts, just that patents increase the incentive to fudge the numbers. Monopoly always increases the incentive for entities to do whatever they can to maintain their monopoly profits and if that means that tampering with data will increase such profits there is no reason why they wouldn’t. They certainly aren’t honest enough not to.
“Provide evidence or leave me alone.”
You just don’t want anyone showing arguments that may threaten the rich and powerful corporations that stand to gain from patents. So you want them censored, just like how our media censors things that threaten rich and powerful corporations.
“As for “me-too” drugs, the implication is that companies are trying to take market share from each other without providing any “real” benefits to patients. Of course, “trying to take market share away” is better known as “competition,” which ultimately results in lower prices.”
Not when they lobby entities like the FDA to over regulate and ban competing products.
A better question is why would a company produce bogus data?
How many years did Wyeth show a loss because of Phen-phen lawsuits?
How much money did Vioxx lose Merck once the lawsuits are added in?
I think in some cases the people are so heavily invested in a project that they may tend to not believe the negative results that come up. Kind of like the parents that just don’t realize all the warning signs that their kid is about to go into a school and shoot it up.
“Look, the study clearly says that the government funds 42% of medical research. The study also clearly says that drug research is a PART of that 42%.”
Yeah, they fund 42 percent of ALL medical research. Not all medical research is drug related. It’s possible to fund 42 percent of medical research AND to fund most drug related research at the same time.
Re: Who Pays for Drug Research
Okay, that might be possible…but that is up to you to prove, which you have yet to do. You are full of assertions, and very little proof.
“A better question is why would a company produce bogus data?”
Ask the companies that do it? Why did they produce bogus data for Vioxx? They did. Why should you assume that it can’t happen again? Because they are too ethical to do so? The fact that it’s happened before is more evidence of its possibility. After the whole Vioxx scandal preemption laws were passed. The only reason why Vioxx was discovered to be bogus is because they didn’t properly destroy the evidence and it was because of the discovery processes that our justice system allows. Now with preemption all that can go out the window. Why do you think Preemption was passed after the vioxx scandal? To prevent them from being caught in the future. Next time they’ll just be more careful about not getting caught and they’ll be more careful about destroying the data. Don’t give me this garbage that such actions are impossible either.
Re: Re:
So, your [unproven] assertion is that patents cause people to falsify data or lie about tests. Let us see if we can think of examples…
The Firestone tire fiasco. Ford blamed Firestone and Firestone blamed Ford. However, patents were NOT at the root of the problem. Oops, I guess your assertion is wrong.
Ford Pintos exploded when hit from the rear. The problem? A design error, not patents. Oops, I guess your assertion is wrong.
How many examples do you want? Companies have tried to hide data, falsify data, etc., and patents were not at the heart of the matter. You have an assertion with, thus far, zero support. You can’t even get a crony to back you up.
and don’t give me that garbage that it’s impossible to get away with. In the case of Vioxx they could have easily gotten away with it with preemption laws (but they weren’t around at that time). Or had they properly destroyed the data.
Communism (allowing the government to allocate resources) leads to corruption (everyone tries to manipulate the government into allocating resources in their direction). Patents are a form of government allocation and are just as subject to corruption.
Re: Re:
You equate patents to communism? Oh, please. If anything, patents are anti-communism. However, you have yet to prove any assertion you have made. Your statement is one of opinion rather than one of fact. I assert that being named Bettawrekonize automatically gives you a chemical frontal lobotomy and removes any logic centers in the brain. The amount of proof I have for that is equal to the amount of proof you have provided for any of your statements thus far.
It’s impossible to prove anything with absolute certainty. Our whole economic model is based on the notion that firms act in their own best interest. Patents increase the incentive to skew data (it’s in their best interest to skew the data of a patented product moreso than a generic) and they certainly aren’t honest enough not to.
Re: Re:
You have yet to explain why a patent would cause a firm to skew data. Let us review…
What is required to get a patent?
– The invention must be novel (i.e., an innovation).
– The invention must be explained.
– There must be a figure unless the invention does not avail itself of being shown in a figure.
Note from my list that there is no requirement for the invention to even WORK (however, if it does not work and the patent is shown to lead to a non-working product, it is subject to being invalidated).
So, I will ask (for the what, fifth, sixth, seventh time?) again, what evidence do you have that patents lead companies to skew data? What about patents causes companies to skew data. Explain. Support. Use logic. Your opinions are fun, but they are not support or logic.
“The Firestone tire fiasco. Ford blamed Firestone and Firestone blamed Ford. However, patents were NOT at the root of the problem. Oops, I guess your assertion is wrong.”
Again, I never said that it doesn’t happen independent of patents, just that patents increase the incentive. You aren’t reading what I am typing, you are building a strawman.
Re: Proof...
Okay, then show me your study that shows that patents increase the incentive for a company to do whatever. Prove your strawman.
Preemption laws? What laws?
Justice Stevens, writing for the majority, which included Justices Kennedy, Souter, Ginsberg, Breyer, and Thomas, held that FDA approval of drug labeling does not preempt state laws or shield companies from legal damages arising from liability claims. In deciding against the application of the preemption doctrine, the majority began its analysis by indicating that the police powers of the states with respect to drug labeling are not preempted by federal law unless that was the purpose of Congress. Justice Stevens’ opinion traced the long history of FDA regulations that worked alongside state law to assure the safety and effectiveness of drugs. The majority opinion emphasized that historically, the burden of ensuring label accuracy ultimately lies with drug manufacturer.
Also, my point about why a company would “fudge” data wasn’t that they don’t do it, my question was why, when countless lawsuits and financial results prove economically that doing so isn’t a good idea, do they do it?
“According to the United Nations Development Programme, less than 5% of drugs introduced by the top 25 pharmaceutical companies in the US represented true therapeutic advances; of these, 70% were developed with government involvement ([20], p. 69).”
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020014
Re: Re:
lol…So, when pinned to the wall you change the subject. Way to [try] to derail the topic.
“Okay, then show me your study that shows that patents increase the incentive for a company to do whatever. Prove your strawman.”
You don’t even know what a strawman is.
Re: Strawman and lack of a logical argument or proof...
And you are trying to derail the conversation from pointing at the fact that you have no evidence of anything.
“You have yet to explain why a patent would cause a firm to skew data. Let us review…”
I have, you simply choose to ignore it.
Re: Re:
Perhaps I was sleeping at the fleeting moment when you presented something. Better clearly restate the data that supports your position.
Incidentally, you are still trying to divert the conversation.
“What is required to get a patent?
– The invention must be novel (i.e., an innovation).
– The invention must be explained.
– There must be a figure unless the invention does not avail itself of being shown in a figure.”
You mean like the patent for swinging sideways (mentioned above). Many patents are nonsense but people like you defend them.
“Also, my point about why a company would “fudge” data wasn’t that they don’t do it, my question was why, when countless lawsuits and financial results prove economically that doing so isn’t a good idea, do they do it?”
If it really isn’t economical for them to do it they wouldn’t. They do so it probably is. You don’t even argue that they don’t, so clearly yo agree that they do.
Re: You need to learn logic...
When someone does not argue a position, it does not mean that they agree with the opposite opinion. I have direct proof that companies DO NOT skew data for anything. I have evidence that companies have skewed data that have NOTHING to do with patents, which does NOT support your dubious position. Examples:
– Reliability of devices.
– Gas mileage figures.
– Energy efficiency.
Probably many more, not one of which would seem to have ANYTHING to do with patents. How many of these skewed results would be any different without patents? Answer: NONE.
“And you are trying to derail the conversation from pointing at the fact that you have no evidence of anything.”
No, you just ignore the evidence and logic. It’s perfectly good evidence and logic but you just ignore it. The fact that you ignore it doesn’t invalidate it.
Re: The Emperor's New Clothes
Your logic reminds me of the Emperor’s New Clothes. Your arguments have just as much substance. Indeed, there is as much substance in your arguments as there is to support an alien landing at Roswell. Hey, I have some spare aluminum foil. Do you need some?
“Better clearly restate the data that supports your position.”
You already ignored it so you would just keep ignoring it.
Re: That is what I thought...
If you had it, you would state it. Since you did not state it, you must not have it. Of course, I am using your logic…if it works for you…
“Justice Stevens, writing for the majority, which included Justices Kennedy, Souter, Ginsberg, Breyer, and Thomas, held that FDA approval of drug labeling does not preempt state laws or shield companies from legal damages arising from liability claims.”
It still preempts federal laws. Usually these cases are very narrowly defined and the courts are subject to change their mind. See, for example, http://content.nejm.org/cgi/content/full/358/18/1883 and the history of the times that the court did uphold preemption laws.
“How many of these skewed results would be any different without patents? Answer: NONE.”
You’re missing the point, that is, without patents, they are less likely to get skewed in the first place.
Re: You still miss the point
And you still miss the point that you have provided zero evidence that patents either tend to lead to skewed results or not lead to skewed results. You have shown no causation whatsoever. You have provided a hypothesis. Support it with a fact.
Mike...I know how you feel right about now...
Mike:
Remember the conversation we had about idiots, or trying to avoid calling people idiots?
I am patiently counting to 1 million…
“The reason it took a decade to ban LSD is that it took the drug a decade to become abused and to cause significant health problems”
Do you have studies to prove that this is the reason?
Re: Re:
More than 40 studies were conducted on the side effects of LSD beginning in 1950 and ending in the mid-1960’s. Interesting that most of these studies were completed in the years just prior to the banning of LSD. These same studies documented the psychotic episodes that sometimes occurred, the complete dissociation with surroundings, often leading to physical injury, and flashbacks that could occur, sometimes years after the last dose of LSD.
I would be happy to start giving you the titles of the individual studies, though it may take a little time.
“And you still miss the point that you have provided zero evidence that patents either tend to lead to skewed results or not lead to skewed results.”
I already explained why such reasoning makes sense. You simply ignore the reasons. Keep ignoring them.
Re: Ohhh...
I see…you provided no proof. You merely provided what you think passes for logic. You fail.
Incidentally, I googled your name. You frequent the conspiracy web sites. Your name is well associated with an array of anti-FDA comments that do have at least SOME support with facts, but a lot of conjecture and non-support as well.
So, you are a conspiracy theorist. In general, my impression of conspiracy theorists is that they are long on theories, and short on facts.
For more examples of products that were banned only after the patent expired see Freeon and ozone therapy. I know a printer who used to use a blanket wash. One day the EPA banned it and he had to buy a less effective, more expensive wash. I suspected that the patent expired and the new stuff was patented, I did some research and sure enough I was right.
Here is another example of a painkiller being banned after the patent expired
http://www.naturalnews.com/025610.html
Sure it may not happen right away but as industries realize that this is competing with their patented products and as the name brand dies and becomes as popular as the generic the incentive to defend its existence decreases (since there isn’t a monopoly anymore).
Re: Geez
Freon was patented in 1928. The patent expired in 1945. Freon was banned in 1996. Let me see, patent expired in 1945, Freon was banned in 1996. That is 51 years between the two events. I see lots of logic for patents causing Freon to be banned.
Re: Re:
Yes, the FDA has been given the results of a series of studies conducted over several decades, and the results indicate Darvon and darvocet, both of which are highly controlled, have safety risks. However, the patent expired more than 30 years ago. Again, I see no causation here.
“And you still miss the point that you have provided zero evidence that patents either tend to lead to skewed results or not lead to skewed results.”
In the case of Vioxx they skewed data. Vioxx was a patented product. They wanted to protect their patented product. Things like that don’t happen with generics.
Re: Re:
Really? You just provided an example of it happening with generics. The Darvon patent expired three decades ago, and continuous studies indicate that the drug has problems. Hmmmm…Since darvocet is a generic and holds the bulk of the market…
Re: Re:
You also miss the point that the vast majority of generics were once patented drugs.
Most of the time when you see that data was being skewed with drugs (and I already gave you examples) it has to do with patented drugs.
The point wasn’t that companies fudge their data, but why, when faced with lawsuits that cause a net loss, they do it.
Either they think they can get away with it (doubtful) or they just don’t believe the risk is there. If that is the case, then profit motives don’t make sense, which puts a dent in your argument. Of course, so does the preemption law that you quoted that doesn’t exist.
Are drug companies saints? Far from it, but they are not demons either.
On another of your points, as an American, I don’t mind that me too drugs are developed that will only be sold in America while drugs are not developed for the 3rd world. It sucks to be them and it was the luck of birthplace that allows me to live here, but better me and mine than them. Can we do more for the world? Sure, but is it right that someone in Africa could get AID’s drugs free while a poor person in San Francisco dies because he couldn’t afford the treatment? That doesn’t seem right either.
“In general, my impression of conspiracy theorists is that they are long on theories, and short on facts.”
In general you just ignore the facts.
Re: Re:
It is easy to ignore what does not exist.
“The point wasn’t that companies fudge their data, but why, when faced with lawsuits that cause a net loss, they do it.”
Ask them. Why do you think they do it? What a stupid question. They do fudge data and they do it because they think it’s in their own best interest. They weigh the probability of getting caught and for the most part they don’t get caught (which is why they do it).
Most of the time when you see that data was being skewed with drugs (and I already gave you examples) it has to do with patented drugs.
Is there any research on drugs that are not on patent? Isn’t most research (data) done on new drugs that would be under patent? If that is the case, wouldn’t all data (fudged or otherwise) be on patented drugs?
“Either they think they can get away with it (doubtful) or they just don’t believe the risk is there.”
You are saying that they don’t think they can get away with it but that they don’t believe the risks are there? That’s self contradictory.
“Is there any research on drugs that are not on patent?”
Yeah. For example, the DCA example I gave earlier.
“These same studies documented the psychotic episodes that sometimes occurred, the complete dissociation with surroundings, often leading to physical injury, and flashbacks that could occur, sometimes years after the last dose of LSD.”
All this was known before the patent on LSD expired.
Re: Studies
Yes, because the studies began in 1950. However, the studies were for the long-term affects of LSD. Note that the patent expired in 1953. I suspect (no evidence) that the studies were started because of the reports of flashbacks, dissociation, etc. Seems they were right.
They knew that LSD was a hallucinogenic before the patent expired. They tested it on monkeys before they did on humans and noticed it acted weird. The discoverer himself tried it on himself and found it to be a hallucinogenic.
Re: Side Effects
Yes, they knew it was hallucinogenic. However, they were as yet unaware of the dissocation phenomenon and how it could lead to people inadvertently killing themselves, the psychosis that some people seemed to acquire, and they absolutely were clueless about the flashbacks that occurred at random, sometimes decades after the last dose – even though there is no apparent genetic damage.
“Is there any research on drugs that are not on patent? Isn’t most research (data) done on new drugs that would be under patent? If that is the case, wouldn’t all data (fudged or otherwise) be on patented drugs?”
The point is that in the case of generics any studies showing a drug to be beneficial helps everyone who sells the drug and still ensures a normal profit. Hence there is not as much incentive to manipulate the data. Monopolies intuitively increase this incentive because skewed data for a particular drug doesn’t mean that others will benefit from those studies (just the person who owns the patent).
Re: Economic Theory
Economic theory says that without patents pharmaceutical companies would have an even greater incentive to skew data. Without patents, a pharmaceutical company’s best hopes to recoup product is to be first and fast to market. The best way to achieve that is to skew data. When a patent is involved, the company knows that they have a monopoly for at least a little while. Without a patent, the only monopoly they have is until another company reverse engineers the drug, conducts their own clinical trials (because the first trials will still be in progress), and puts the drug on the market. Logic dictates that speed will become the most important factor in making profits.
Re: Huh?
Once a patent expires, the generic manufacturer piggybacks off the studies conducted on the patented drug; i.e., the clinical trials in the pre-release and post-release phases benefit the generic producer because they do not need repeated when the generic producer applies to the FDA. So, skewed data “benefits” (if you can call the lawsuit and billions of dollars in penalties a benefit if the data is skewed and the skew causes deaths) both the patent holder and all eventual generic producers. Indeed, generic producers use the “skewed” data to help sell their product.
“More than 40 studies were conducted on the side effects of LSD beginning in 1950 and ending in the mid-1960’s. Interesting that most of these studies were completed in the years just prior to the banning of LSD. These same studies documented the psychotic episodes that sometimes occurred, the complete dissociation with surroundings, often leading to physical injury, and flashbacks that could occur, sometimes years after the last dose of LSD.”
Those studies were by the CIA and they were intended to see if LSD can be used as a truth serum. When they found out it can’t be used for that, there was no reason to keep it around (since it was no longer patented) so it got banned.
“More than 40 studies were conducted on the side effects of LSD beginning in 1950 and ending in the mid-1960’s. Interesting that most of these studies were completed in the years just prior to the banning of LSD. These same studies documented the psychotic episodes that sometimes occurred, the complete dissociation with surroundings, often leading to physical injury, and flashbacks that could occur, sometimes years after the last dose of LSD.”
http://en.wikipedia.org/wiki/LSD
Re: So...?
I am unable to answer as to whether ALL the studies were conducted by the CIA. Regardless, what does that matter? If anything, the CIA had no incentive to skew data, they were just interested to see how LSD behaved. Furthermore, many of those studies were conducted at an array of universities, whose professors are notoriously meticulous and honest. So, when the dangerous side-effects of LSD were observed by dozens of objective scientists, I am guessing that was compelling evidence sufficient to convince congress of the dangers of LSD.
Beginning in the 1950s the Central Intelligence Agency began a research program code named Project MKULTRA. Experiments included administering LSD to CIA employees, military personnel, doctors, other government agents, prostitutes, mentally ill patients, and members of the general public in order to study their reactions, usually without the subject’s knowledge. The project was revealed in the US congressional Rockefeller Commission report.
http://en.wikipedia.org/wiki/LSD
(I meant to paste that but I re – pasted your post instead. Guess the other one didn’t copy right).
Another thought is that all drugs have risks. Some more than others. Vioxx seems to be the current poster child of this, but my mother in law was on Vioxx. She wishes she could go back on it, even knowing the risks. She was better off on it than she is now.
Along the same lines, the HPV vaccine Gardisil is being pushed yet there are potentially 32 deaths that may be connected to this. How many lives will be saved? What is the equation? Is saving 100 lives worth the 5 people that may be killed by the drug? How do you calculate that?
Glaxo “buried” data for Welbutrin that may have shown that it causes suicides in young users, Spitzer went after them and now Glaxo puts all its clinical trial data online (something I support, but doubt it will really do much) yet later academic studies showed that Welbutrin doesn’t cause young users to commit suicide.
We know what we know when we know it, not before.
“Again, I see no causation here.”
That’s just your opinion, but the evidence says otherwise.
Everything has the potential of safety risks. It’s safer to give them a drug that’s been studies for 30+ years (where we know the risks) than to give them a new drug, where we don’t know the risks. If this was really unsafe why not ban it before the patent expired? The reason it was banned after the patent expired is because it competes with patented products. Otherwise, the patient should have the opportunity to choose whether or not they want to take the drug. The FDA shouldn’t choose for them and I don’t buy the nonsense that the FDA has our best interest in mind. They did it because it competes with patented products.
Re: Re:
You obviously know nothing about drugs, populations and the scientific method.
Yes, it is my opinion that there is no causation, but neither have you offered evidence that “says otherwise.”
Now, you asked a question, “if this was really unsafe why not ban it before the patent expired?”
Realize first that your question is neither logic nor evidence, but a query into why a drug was banned only after a patent had expired. Let us explore this question.
Clinical tests by necessity involved dozens and hundreds of people. The use of the drug is extremely carefully controlled and monitored. However, there are problems with clinical tests.
The first problem, of course, is that there are not enough participants. If the number of participants in a clinical trial is 5,000, and an effect is noticed in 1 person (mathematically 0.02%), the researcher will document the result, but will not know whether the effect was caused by genetics, a life style factor, or the drug itself. When the number of users goes to 1 million, now the effect is observed in 200 people and factors such as genetics, life style, etc., may be better factored into the observations. When the number of users is 10 million, now the effect is noted in 2,000 people, and researchers can figure out better why the effect is observed. This was the scenario with Lipitor and other similar drugs and the rare but potentially fatal side effect that caused advisories to be issued regarding possible side effects.
The second problem is the length of time. Because of how the body functions, some effects may be unobserved until several decades after the beginning of treatment. For example, if a drug leaves a microgram of toxin in the liver after a week, it may take two or three decades of usage for the toxin to have a significant effect on the patient. Since it takes a lengthy period of time to conduct initial clinical trials, by the time a patent goes on sale to the time its patent expires can easily be 10 to 15 years, hardly enough time to observe long term effects.
Though these two factors are probably among the most significant, there are numerous other factors that can change the effectiveness or toxicity of a drug. As new drugs come on the market, previously unseen interactions may develop. Other conditions or environmental factors may develop that were previously unobserved.
Regardless of the reason, it is likely that if there are problems with a drug that they will not be detected until after a patent expires just because patents do not last very long and human trials essentially go on as long as there are humans. We are still studying the effects of aspirin, which has been generic for decades.
You should also consider that while the FDA bans drugs, states may also ban drugs and Congress can require the FDA to ban drugs (all of which have happened). To say that expiration of patents causes drugs to be banned is very twisted logic indeed when there are better, more logical explanations available.
“Another thought is that all drugs have risks.”
Exactly my point, which is just more evidence that the above was simply banned because it competes with patented products.
It’s amazing how you would use the “all drugs have risks” argument for patented drugs but you don’t use it for unpatented banned drugs.
Aspirin competes with patented products and due to its safety record, probably wouldn’t be able to gain FDA approval today if it were new. Why hasn’t that been banned?
Re: Aspirin
You are absolutely correct. There have been several articles pointing out that because aspirin can be incredibly toxic and has long term affects, many of which were unknown until…wait for it…DECADES after aspiring began to be used, it probably would not be approved today. There has even been some discussion of banning aspirin (mostly speculative, I do not believe there was ever a serious attempt to ban aspirin).
However, since there are plenty of patented painkillers, why is ibuprophen still around? What about generic Advil? Seems like all these generics should be banned because there are patented alternatives. Before the patent on Tylenol expired. By Betta’s logic, Tylenol should be banned.
“roflmao…DCA is the subject of several patent applications, but apparently the FDA has concerns about safety. So, since DCA for the treatment of cancer has patent applications filed, and yet the FDA has banned the use for the treatment of cancer, how does that fit with your little conspiracy mind?”
No, it was already being sold as a generic (no patent) when the FDA banned it. They later decided to have it as a potential patented drug for cancer (and now they’re trying to unban it as that). Read the link I gave you (and the relevant post for the history). As a generic (for other things) we already had a pretty good understanding of its safety ramifications. The people who were getting DCA for cancer had TERMINAL cancer and the FDA prevented them from getting the generic DCA. It was simply banned because they were afraid it would be discovered as a good cancer treatment and hence would compete with patented products.
Re: DCA
Betta:
I am no longer looking at your links. Each one I look at does not say what you says it does, or it is by another conspiracy theorist with an axe to grind or yet more bizarre theories. Try giving some real evidence instead of a conspiracy theory.
A drug is not a “generic” if it has no patent. It is merely a drug.
DCA was banned because it is essentially a highly toxic poison that has numerous, well-documented side effects. Why not just take arsenic and cross your fingers that it will blunt the effects of cancer? Actually, it does, you know. If you take arsenic long enough you no longer have to worry about cancer.
“but apparently the FDA has concerns about safety”
The FDA had concerns about its safety for terminal cancer patients? The nonsense. Read up on the whole subject, if you want more links to people who already argued this just ask.
Re: Re:
If you had been credible on any post up to now, I might be reading more about DCA from your links. The links I looked at stated that DCA is highly toxic and deserved to be banned.
Not to mention the research on DCA as a potential cure for cancer was tax funded.
but of course some specific entity gets the patent and they benefit from tax dollars.
I think that some patents are beneficial for advancing technology but I think we need to make it MUCH more difficult to obtain patents and we should greatly shorten the time that patents last. In addition perhaps we can cap the royalties that a patent holder can receive if another company sells a generic.
But our current patent system is a joke. It’s riddled with corruption and creates huge incentive to skew data and we desperately need patent reform. In addition, in the case of pharmaceutical drugs, if any federal funding was used to develop any drug whatsoever, there should be no patent.
[quote]
“The most important of these laws is known as the Bayh-Dole Act, after its chief sponsors, Senator Birch Bayh (D-Ind.) and Senator Robert Dole (R-Kans.). Bayh-Dole enabled universities and small businesses to patent discoveries emanating from research sponsored by the National Institutes of Health, the major distributor of tax dollars for medical research, and then to grant exclusive licenses to drug companies.”
[/quote]
This needs to be changed.
[quote]
“Second, the pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH).”
[/quote]
http://www.nybooks.com/articles/17244
So answer me, why should taxpayers pay for innovations only to have rich corporations gain the patents?
Re: Betta
Finally you say something that makes sense.
AS Mike Masnick has pointed out many times, and as evidence has seemed to confirm, with the exception of a few universities, the Bayh-Dole act appears to have harmed universities.
It is also true that the number of drugs coming from the pharmaceutical industry has declined significantly in many years (though some anti-patent foes dispute this for reasons that still escape me). However, the decline in new drugs was foreseeable. The pace at which drugs are going off patent is accelerating, and soon big pharma will be much smaller. Thousands have already been laid off in the industry, with more to follow. As others have noted, when you most valuable product is marketing, and people see that your product is too expensive compared to the alternative, you will fail.
However, once again another author has couched taxpayer funding in a way that is deceptive and yet again fails to generate any real facts. Note that the source of new drugs included private companies. Hmmm….
So, you provided a good post, one of your best, but it fails to prove that taxpayers fund the majority of new drugs going on the market.
“Hey, I have some spare aluminum foil. Do you need some?”
Equating someone who believes in tin foil hats with someone who believes that our government and corporations are subject to corruption are not the same thing. Corrupt governments (and businesses) have existed practically all throughout history, it’s not unreasonable to conclude that corruption still exists today.
Re: Yes, but...
You have continually made the claim that patents cause corruption. I, and several others, have disputed that. After repeated requests for evidence and proof, your only evidence is that drugs are banned after patents expire. As I have pointed out to you, there is some correlation, but not causation. There are other factors at play that you fail to consider. Once you wake up to that likelihood you may take your aluminum hat off. In the meantime, back to your research.
“Not when they lobby entities like the FDA to over regulate and ban competing products.”
So Me too drugs get banned? I thought me too drugs were a current problem with our system? If they are all banned, I don’t see the problem.
Re: Consistency
AC:
I would not expect much consistency from Betta. His forte lies in finding issues where there are none, even if the issues are contradictory. Explaining why things are issues appears to be something he does poorly.
“So, when the dangerous side-effects of LSD were observed by dozens of objective scientists, I am guessing that was compelling evidence sufficient to convince congress of the dangers of LSD.”
again, if it were really so dangerous, they would have banned it before the patent expired.
Re: Expirations & Banning
Betta:
I will try, once again, to give you a chronology.
1948 – Patent for LSD issues.
1950 – Multiple long term studies of LSD begins.
1953 – LSD patent expires.
1960-1965 – The dangerous side effects of LSD are recognized.
1962 – Criminalization of LSD initiated.
1966 – LSD banned.
So, would you have LSD banned after the patent expired but before the dangers of LSD had been quantified? Where is the logic in doing that?
“You obviously know nothing about drugs, populations and the scientific method.”
I know how the scientific method is “supposed” to work but to say that science operates in a vacuum, independent of politics, is absolute nonsense.
Re: Scientists...
So, all the scientists who have ever studied drugs have been suppressed by the government. Is that what you are saying? Are you saying that scientists have the results of long-term studies in a couple of years (I fail to see the logic in that), but are suppressing them until after the patent expires? Are you saying that scientists, universities, the government and pharmaceuticals are ALL conspiring to hide information about the negative effects of drugs until the patents expire?
“After repeated requests for evidence and proof, your only evidence is that drugs are banned after patents expire.”
I have pointed out that most of the time that they skew data it has to do with patented drugs and I have pointed out why it makes sense if one only assumes, as economic theory assumes, that entities act in their own best interest. You simply ignore the facts.
“I am no longer looking at your links. Each one I look at does not say what you says it does, or it is by another conspiracy theorist with an axe to grind or yet more bizarre theories. Try giving some real evidence instead of a conspiracy theory.”
I rest my case. You simply ignore any information that disagrees with your presuppositions by labeling them, “conspiracy theories.” You think giving them a label proves your side. Just disregard it as a crazy conspiracy theory simply because you disagree with it a priori. How scientific.
“A drug is not a “generic” if it has no patent. It is merely a drug.””
What’s the difference?
“The links I looked at stated that DCA is highly toxic and deserved to be banned.”
It was approved by the FDA at one time to treat chronic lactic acidosis. It was once patented and we understood the clinical trials ramifications. The people who were getting better (in the unsanctioned clinical trials) already had terminal cancer, so what harm can it do? They are already considering unbanning it once it gets a patent, so clearly it’s not toxic enough to be banned.
“DCA is a common chemical that has no profit potential for big pharma so even though it shrunk several different types of human tumors in immuno-compromised rats 75% in 3 weeks with no adverse side effects, and even though it’s been used for decades in humans in treating chronic lactic acidosis so its safety was already well characterized in humans, no one will put up the hundreds of millions of dollars to test its efficacy as a chemotherapeutic for cancer.”
http://www.uncommondescent.com/biology/dca-update/
Not to mention that you just made up the notion that DCA is so toxic while providing zero evidence. Sure it may have risks, but all drugs have risks.
“1960-1965 – The dangerous side effects of LSD are recognized.”
What dangers? Anything has potential risks, legal antidepressants can be abused and cause people to do stupid things. The solution that they do is to simply make sure that doctors prevent people who won’t react properly with it from obtaining it.
Re: Dangers
You simply ignore any information that disagrees with your presuppositions by saying, “anything has potential risks.” You think by saying that proves your side. Just disregard it simply because you disagree with it a priori. How scientific.
Incidentally, links were provided to two different places where the dangers of LSD were discussed. To summarize:
– The dissociation caused by LSD has caused people to die because they wandered into dangerous situations.
– Psychosis caused by LSD can be long term. In some cases, the psychosis may leave permanent effects, including permanent disability.
– Flashbacks may occur unexpectedly even decades after the last use. Such flashbacks can happen at any place and at any time, and there is no known method of predicting them.
Seems to me that these side effects are enough to cause concern.
“So, all the scientists who have ever studied drugs have been suppressed by the government. Is that what you are saying?”
No, now you are putting words in my mouth. Keep ignoring the facts.
Re: Re:
Okay, then correct me.
“DCA was banned because it is essentially a highly toxic poison that has numerous, well-documented side effects.”
Every drug has documented side effects. As far as the highly toxic, the FDA didn’t seem to think that before the patent expired.
Re: Re:
Interesting. As far as I can tell, there are roughly 45 U.S. patents that claim the use of dichloroacetate (DCA) and that may be in force (I did not check whether maintenance fees were paid on all 45). You may find the list:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.htm&r=0&p=1&f=S&l=50&Query=ACLM%2Fdichloroacetate&d=PTXT
The assignees include pharmaceutical companies, universities and business. The most recent medical related patent issued in late 2008.
So, how does the existence of 45 patents that may be in force in the United States, held by universities, pharmaceutical companies and businesses, support your hypothesis that the drug was banned “after the patent expired”?
Besides, DCA isn’t banned for its original use, it was simply banned for terminal cancer patients.
“1960-1965 – The dangerous side effects of LSD are recognized.”
Again, all of that was already known before the patent expired. Show me documents stating that these studies are the reason it was banned? Show me proof.
Re: Re:
Flip that around. Show me proof that LSD was banned in the late 60’s because the patent expired in the early 50’s.
On the contrary, here is yet another link ennumerating the dangers of LSD:
http://www.druglibrary.org/schaffer/LIBRARY/studies/cu/CU51.html
Indeed, this article explains that the severity of LSD abuse and the side effects increased throughout the 1960s. This article provides reasons that may have been the case. I infer from the comments at the end of this article that the side effects that increased in severity in the 1960’s was the reason LSD was banned.
Now, present your “superior” evidence.
“You are absolutely correct. There have been several articles pointing out that because aspirin can be incredibly toxic and has long term affects, many of which were unknown until…wait for it…DECADES after aspiring began to be used, it probably would not be approved today.”
Do you have 30+ year comparative studies showing that this older drug is safer, in the long term, than newer patented drugs? Do you have any evidence that the newer patented drugs are safer in the long term than this one? Prove to me that the reason it was banned is because it’s more dangerous, in the long term, than more modern patented drugs.
At least with older drugs we know the long term side effects so the patient and doctor can better weigh the pros and cons. With newer drugs one can’t really do that. It should be up to the patient to weigh the pros and cons, the patient has his/her own best interest in mind, not the FDA. The FDA is subject to conflicts of interest and there is little reason to believe that the FDA in any way has anyone else’s best interest but its own.
Re: Re:
How is my comment relevant to any questions you asked? The observation was made that long term studies have shown that aspirin has dangerous, including lethal, side effects. The observation was made that the patent on aspirin expired decades ago. The observation was made that the drug has not been banned. These are not points of debate, they are observations. Use them as you will.
“To say that expiration of patents causes drugs to be banned is very twisted logic indeed when there are better, more logical explanations available.”
They increase the incentive for competing unpatented products to be banned, not that they cause them all to be banned.
“Seems to me that these side effects are enough to cause concern.”
All side effects are enough to cause concern, that’s true of any drug. All drugs have risks.
“Once a patent expires, the generic manufacturer piggybacks off the studies conducted on the patented drug”
By then the pharmaceutical company has already made a huge profit from the skewing of data. Then, like in the case of LSD, there is incentive to find a bunch of reasons to ban the generic (ie: conduct more studies and skew that data, etc…).
“Economic theory says that without patents pharmaceutical companies would have an even greater incentive to skew data.”
No, because doing so still means everyone earns a normal profit. Monopolies make it easier to not earn a normal profit and skewed data can maximize that.
“Logic dictates that speed will become the most important factor in making profits.”
Clearly, in the case of LSD and the other banned drugs, the alleged dangers weren’t found during the time (or before) of the patent. So the patent system didn’t stop dangerous drugs from getting out and it doesn’t.
“Indeed, this article explains that the severity of LSD abuse and the side effects increased throughout the 1960s. This article provides reasons that may have been the case. I infer from the comments at the end of this article that the side effects that increased in severity in the 1960’s was the reason LSD was banned.”
But they didn’t have to ban the stuff. They could simply tighten regulations to prevent it from being abused. But since it’s just a generic and hence there is no special interest group with monopoly profits protecting its existence, it gets banned instead. It was banned only after the patent expired, during it being patented there is incentive to lobby for its existence and to skew data (and hide data) to keep it legal.
“Interesting. As far as I can tell, there are roughly 45 U.S. patents that claim the use of dichloroacetate (DCA) and that may be in force (I did not check whether maintenance fees were paid on all 45). You may find the list:
So, how does the existence of 45 patents that may be in force in the United States, held by universities, pharmaceutical companies and businesses, support your hypothesis that the drug was banned “after the patent expired”?”
Those are patents for other uses.
But the fact that it’s not banned, for patented purposes, is just more evidence that toxicity (as you state) is not the reason that the FDA prevented terminal cancer patients from initially using it (as an unpatented product for that use).
The patent systems isn’t designed to stop dangerous drugs from getting to the market. That is the FDA’s job. When long term problems show up (or problems that were not discovered, or were covered up)after a drug is on the market, then it is also the FDA’s job to get that drug off the market. Patents have nothing at all to do with that process.
“DCA was banned because it is essentially a highly toxic poison that has numerous, well-documented side effects.”
Even as you state, it’s not banned for patented reasons, so are you saying it’s only toxic as a non – patented product for terminal cancer patients? But as a patented product (now that they want to get a patent for that product) it’s fine?
Re:
Ah, at last. A reasonable hypothesis.
The expiration of a drug increases the incentive for competing unpatented products to be banned.
Okay, you have a hypothesis. Do you have proof to back up your hypothesis? Additionally, if it has happened, has it happened enough times to warrant congressional action? Just because someone commits a crime once does not predicate they will do it again, or that they will have the opportunity to do it again.
For that matter, pharm companies should be pressing for the banning of aspirin in favor of patented pain killers, yet, they do not seem to be in a hurry to do so.
Re:
Yeah, death is a common side effect to all drugs. Wait, death is a secondary effect due to the dissociation caused in some users. Couple the lack of utility in LSD with the dangerous side effects and you have a case for banning the drug.
“The patent systems isn’t designed to stop dangerous drugs from getting to the market. That is the FDA’s job. When long term problems show up (or problems that were not discovered, or were covered up)after a drug is on the market, then it is also the FDA’s job to get that drug off the market. Patents have nothing at all to do with that process.”
So then, by your own logic, the notion that, “Economic theory says that without patents pharmaceutical companies would have an even greater incentive to skew data. … Logic dictates that speed will become the most important factor in making profits.” is irrelevant since the FDA’s job is to stop that. So your logic is then flawed.
“For that matter, pharm companies should be pressing for the banning of aspirin in favor of patented pain killers, yet, they do not seem to be in a hurry to do so.”
I don’t expect them to publicly announce such a hurry.
“The expiration of a drug increases the incentive for competing unpatented products to be banned.”
The patent system, as a whole, causes incentive to skew data.
Re:
It was banned because no one could figure out what to use if for, in combination with the increasing number of issues with the drug. The patent was irrelevant. The original inventor of the drug no longer cared because the drug had no effect on their business. Indeed, the article I linked to just above, after explaining how serious the side effects were, turns around and says there are ways of dealing with the side effects and suggests that LSD be taken off the banned list.
So, in conclusion, LSD has a lot of serious side effects, as do many drugs, but as long as it had no known uses, the banning was appropriate. Since there is some indication that LSD may be useful to treat some conditions, it may be the time to take it off the banned list, which is not a pharmaceutical issue, it is an FDA issue.
In the meantime, several universities overseas are beginning experimentation with LSD again to treat certain medical conditions.
“You simply ignore any information that disagrees with your presuppositions by saying, “anything has potential risks.””
No, I am not ignoring the information, I am just point out that these risks didn’t matter when the drug was patented. They only matter after the patent expires.
Re:
Why do you mix patents and danger? The two are absolutely, completely unrelated. The USPTO does not judge on the danger of a patented knife, gun, hand grenade, chemical, pharmaceutical or any other invention. The FDA judges whether a patented pharmaceutical should be allowed to be given to humans.
Re:
And, incidentally, you are wrong in your comments regarding skewing data and speed.
Once again: If speed to market is important to be the first, which also provides the opportunities for the greatest potential profit, then it is in the best interests of a company to skew data to speed the approval process up – thus beating competitors. This statement is based on support from a huge array of researchers, including Boldrin & Levine, a huge crowd of people at AgainstMonopoly.org, where being first has been stressed as critically important, and to some extent on this web site. If being first is important in a world without patents, there is a HUGE, even BIGGER incentive than would exist with patents to skew data. Think this statement through carefully before you respond again with the same erroneous response.
Re:
Other uses than what?
“Indeed, the article I linked to just above, after explaining how serious the side effects were, turns around and says there are ways of dealing with the side effects “
Exactly, and this is true for any drug. The reason LSD was banned is because the patent expired (instead of finding other ways to deal with the side effects, they simply banned it).
“and suggests that LSD be taken off the banned list.”
It’s still banned. The author may think it should be unbanned, but the only way that would happen is if the patent for would be competing patented products expire and they don’t get replaced by new patented products. Then there is less reason to keep LSD off the market as it would maximize industry profits.
So which is it, is it toxic enough to warrant a ban or not? If not, then why was it banned?
You are contradicting yourself. First you say.
The patent systems isn’t designed to stop dangerous drugs from getting to the market. That is the FDA’s job. When long term problems show up (or problems that were not discovered, or were covered up)after a drug is on the market, then it is also the FDA’s job to get that drug off the market. Patents have nothing at all to do with that process.
Then you say
If being first is important in a world without patents, there is a HUGE, even BIGGER incentive than would exist with patents to skew data. Think this statement through carefully before you respond again with the same erroneous response.
“Other uses than what?”
chronic lactic acidosis
The 45 patents you mention are for 45 different uses. You really don’t know what you are talking about do you.
Why else would there be 45 DIFFERENT patents on the SAME drugs? They are for DIFFERENT uses. You are lost.
err, sp, same drug *
BTW, I am not defending the use of LSD nor am I saying that it shouldn’t be banned. Perhaps it should. I am merely pointing out that the alleged dangers didn’t seem to matter before the patent expired, only after.
“This statement is based on support from a huge array of researchers, including Boldrin & Levine, a huge crowd of people at AgainstMonopoly.org, where being first has been stressed as critically important, and to some extent on this web site.”
Yes, I understand this, which is just more reason why patents aren’t that necessary for companies to invest in R & D of new products.
I don’t have a problem with the patent system per – se but I think that the existing system needs huge reform. Patent periods should be much shorter and it should be much more difficult to get a patent (and perhaps one can add a cap on the royalties an entity may receive if another entity wants to manufacture a patented product).
More on LSD toxicity.
“LSD is generally considered nontoxic, although it may temporarily impair the ability to make sensible judgments and understand common dangers, thus making the user more susceptible to accidents and personal injury.”
http://en.wikipedia.org/wiki/LSD
If you read on, you find that LSD does have risks and side effects, but find me a drug that doesn’t. However, I would argue that LSD isn’t necessarily much worse than other unbanned drugs.
One also has to realize that the pharmaceutical industry spends a lot of money on lobbying (probably more than any other industry). Most of that comes from manufacturers of patented drugs. It’s easier for a concentrated source with monopoly power to lobby the government than for a bunch of disperse sources making a normal profit.
“There are other factors at play that you fail to consider.”
I don’t doubt that other factors exist and also cause corruption as well. I never argued against this.
“In the meantime, back to your research.”
I’m not the one that’s lost.
Re:
More on LSD toxicity.
“LSD is generally considered nontoxic, although it may temporarily impair the ability to make sensible judgments and understand common dangers, thus making the user more susceptible to accidents and personal injury.”
http://en.wikipedia.org/wiki/LSD
If you read on, you find that LSD does have risks and side effects, but find me a drug that doesn’t. However, I would argue that LSD isn’t necessarily much worse than other unbanned drugs.
Wikipedia is not an authoritative source on LSD toxicity. In fact, it’s not an authoritative source on anything. For all you know, I could have been the one that wrote that passage on Wikipedia. Stop citing it as an authority for your cockamamie theory.
Further, stop citing your stupid intelligent-design blogs and bible-thumping message boards as authority for your rantings. They are not authored by anyone who has any credibility on this subject. All they do is preach propaganda, not scientific data or factual history.
Your authorities have no credibility. As such, your theories have no credibility. Take the tin-foil hat off and get a job; you’ve wasted far too much time here trying to feed people your Kool-Aid. Nobody buys your nonsense.
So...?
“If anything, the CIA had no incentive to skew data”
That could be the single most assanine thing anyone has said. Ever. The CIA is in the business of intelligence and MISinformation. They probably skew more data than any other entity on the planet.
“Further, stop citing your stupid intelligent-design blogs and bible-thumping message boards as authority for your rantings. They are not authored by anyone who has any credibility on this subject. All they do is preach propaganda, not scientific data or factual history.”
You are unable to refute what I said so you want it censored. You want anyone who disagrees with you, whom you can’t refute, to stop claiming anything (and you want people to stop using citations that you disagree with) simply because you can’t refute them. Wanting opposing views to be censored is not science.
“Your authorities have no credibility. As such, your theories have no credibility. Take the tin-foil hat off and get a job; you’ve wasted far too much time here trying to feed people your Kool-Aid. Nobody buys your nonsense.”
So you can’t refute what I said so you simply dismiss it because it disagrees with you. Excellent science. Don’t bother trying to attack the arguments, just dismiss them and claim that those who disagree with you are crazy simply for disagreeing with you.
“Wikipedia is not an authoritative source on LSD toxicity.”
There are many other sources, but you will simply ignore them too. I can direct you towards them if you like.
“Deaths caused by primary LSD effects have not been well documented. The lethal dose of LSD has been estimated to be 14,000 mcg. Few cases of massive ingestions have been reported; because of its large index of toxicity, patients must have access to unusually concentrated forms of LSD if they are to overdose. Massive overdoses can lead to respiratory arrest, coma, emesis, hyperthermia, autonomic instability, and bleeding disorders. No suicide attempts using LSD intoxication have been reported.”
http://emedicine.medscape.com/article/1011615-overview
Again, LSD is not very toxic.
“If LSD was a medicine it should be considered harmful for usage. Poisoning from an overdose is practically impossible, because the toxic dose is thousands times greater than the one that affects the perception senses of a person; it’s not known anyone to have died from LSD.”
http://library.thinkquest.org/C0115926/drugs/lsd3.htm
The minute doses that cause death in animal experiments may give the impression that LSD is a very toxic substance. However, if one compares the lethal dose in animals with the effective dose in human beings, which is 0.0003-0.001 mg/kg (0.0003 to 0.001 thousandths of a gram per kilogram of body weight), this shows an extraordinarily low toxicity for LSD.
http://nepenthes.lycaeum.org/Drugs/LSD/ProbChild/Chapter2.html
“That could be the single most assanine thing anyone has said. Ever. The CIA is in the business of intelligence and MISinformation. They probably skew more data than any other entity on the planet.”
Most of what we see on the mainstream media is complete nonsense. They think that by censoring the opposition they can make their side more true. Even the people who disagree with me on these forums want me censored, that’s why they tell me to stop saying things that disagree with them.
“Death caused by the direct effect of LSD on the body is virtually impossible. However, death related to LSD abuse has occurred as a result of the panic reactions, hallucinations, delusions, and paranoia experienced by users.”
http://www.narconon.ca/LSD.htm
But most of this regards people who shouldn’t be taking it in the first place. Doctors should be the ones to determine who should and should not be taking it. But since the patent expired, the solution is to ban it. Sure, it may have side effects and risks, but ALL drugs do.
and many of the effects of LSD are only at high doses anyway. Any drug in high doses can be bad.
“The mental effects most commonly associated with LSD use, particularly at high doses, are visual images or hallucinations, often involving simulated philosophical or religious connotations.”
From your link
“Patients and others who took LSD before 1962 received precisely measured doses. When the curtailment of the Sandoz supply triggered the clandestine manufacture of black-market LSD, no such precision was possible.”
http://www.druglibrary.org/schaffer/LIBRARY/studies/cu/CU51.html
There is a potential to create a black market for any drug and to have people take incorrect doses. For any drug incorrect doses can be harmful. The solution, as with any other drug, is to stop the black market usage of the drug, not to ban the drug. The black market will continue even if you ban the legal use of the drug, we shouldn’t ban drugs just because there is a black market. The drug was banned only after the patent expired.
“Contamination. Some of the black-market LSD available after 1962, as noted earlier, was of excellent quality. But other batches, synthesized by amateurs, were contaminated.”
So you ban contaminated LSD. Any drug has the potential of being contaminated, but the solution, as with any other drug, is to remove contaminants.
“4. Adulteration. In addition to contaminants accidentally introduced into black-market LSD through errors of synthesis, some black-market suppliers deliberately adulterated their LSD with a variety of substances, including amphetamines * and even strychnine.”
Again, the solution is similar. As with any drug, stop the adulteration, don’t ban the drug altogether.
So your link doesn’t really help you, if anything, it’s more evidence to the fact that LSD wasn’t banned for any good reason.
Or rather, that the justification for banning LSD after the patent expired wasn’t much greater than the justification before.
By definition, the black market is the illegal sale of a drug. You don’t stop the illegal sale of a drug by banning the legal sale. So your link doesn’t help you in that regard.
Sometimes you gotta be explicit...
Okay, let me spell it out for you…
Your hypothesis is that companies skew data to get FDA approval, and this skew somehow involves patents (that makes no sense, but whatever).
One advantage of the patent system is that it protects the company developing the drug during the development process. No one else is likely to file a patent application once the first application on a drug has been filed. While there is some incentive to be fast, there is more incentive to be accurate because of the potential for lawsuits.
Take away the protection patents provide that allows a company time to develop and test a drug, then speed because the primary factor, not safety. The incentive to skew data INCREASES substantially.
These statements are not contradictions, they are logical.
“While there is some incentive to be fast, there is more incentive to be accurate because of the potential for lawsuits.
Take away the protection patents provide that allows a company time to develop and test a drug, then speed because the primary factor, not safety. The incentive to skew data INCREASES substantially.”
The incentive for lawsuits exists with or without a patent system. So, no, your logic does not hold.
Another difference is that a company with patents has a monopoly so, with increased centralized funding, they have more resources to manipulate government with conflicts of interest. This makes it less likely they will get caught and lose cases. Not to mention, if a company has a bunch of patents and they get sued, it won’t ruin them because as a monopolist they have more money to withstand being sued and the destruction of their reputation does not mean that people will go to competitors. If a company with no patents gets sued because they did something wrong, people won’t trust that company and they can simply switch to competitors. If the product you need has a patent one has no choice.
So companies without patents have a much higher incentive to be honest because getting caught means a bad reputation which means much fewer customers (since competitors exist). With a patent, customers have no choice, they can’t simply switch to competitors because they don’t like the company.
“Take away the protection patents provide that allows a company time to develop and test a drug, then speed because the primary factor, not safety. The incentive to skew data INCREASES substantially.”
A company making a normal profit doesn’t want to get sued because they are less able to withstand the cost of litigation (or negotiation) and especially the cost of losing (not to mention they don’t have as many resources to defend themselves). A monopolist is more able to withstand such costs.
Notice I am not against patents per – se. I do think there are situations (even in medicine and pharmaceuticals) where patents can and do (and have) increased innovation. If used properly I think they could (and do). However, I think our current patent system has way too many problems (and I’ve mentioned them already and possible solutions).
Merck and its Phony Journal
More on this at:
Merck Published Bogus Journal: http://www.newsinferno.com/archives/5921
Normal Profits
You are still missing a point. I am surprised that you require these detailed explanations, but I will try, once again.
Okay, as has been EXTREMELY WELL DOCUMENTED and FREQUENTLY DISCUSSED, the first developer of a drug, even if they have government support, tends to incur more expense than the first copier, who will be trying their best to figure out how to reverse engineer the drug as soon as possible.
So, what is “normal” profit for the first developer of a drug? If the first developer incurs a $50 million cost to develop, and the second developer only incurs a $10 million cost, and if both, because of competition, charge the same price, then the first developer will automatically make a lower “normal” profit because of the greater cost incurred.
However, the first developer is still ahead of the second developer, so for a time the first developer will be able to charge a higher price for the drug, and will continue to do so until the second developer’s copy is approved.
Because the first developer knows the window to charger a higher price and to recoup the greater expense of being first to market, the first developer wants to get the drug into production as quickly as possible and as widely as possible to be able to charge a higher price until the second producer comes on board.
Because the first developer knows that time to market is critical without patent protection, and window to charge higher prices is very small, the first developer will take any action, including what the first developer considers a “reasonable” risk that the drug may ultimately prove to have negative side-effects. While reasonable may not turn out to be reasonable in the long run, in the short run the decisions will be made with minimal data, hoping that long term studies, which will take decades, will prove the decision correct.
As you correctly pointed out, the monopolist can better withstand a lawsuit, and until the second developer gets the drug to market the first developer is effectively a monopolist. Without patents, the incentive is to be first with the monopoly with the hope that the monopoly will be kept as long as possible.
Seitching Companies
Let me think about this. I was on a patented drug, Lipitor, and I was one of those “rare” individuals that had a reaction to it. Oh my gosh! I am unable to switch to a competitor because Lipitor is patented! Oh, no! What should I DO!
*Sigh* I did what any normal person did, I went to a competitor and took a “me-too” drug to which I had no reaction (uh, oh, you mean ME-TO drugs have a benefit to someone who is unable to take the earlier drug? What does that do to all my theories about me-too drugs being worthless?). Fortunately, I had no reaction to the me-too drug, which shows that:
(1) Me-too drugs are in fact different enough that they may not have the same side effect as the original (which is why warnings for me-too drugs are often different from the original, because the supposed “minimal, non-meaningful differences” between drugs can in fact be meaningful).
(2) Me-too drugs are worth having. Certainly to me.
Re:
The incentive for lawsuits DOES exist with or without patents. However, when evaluating risks, with the elimination of patents suddenly the need for speed is weighted greater than it was previously, and suddenly the amount of risk a company will take may increase when the only option to obtain monopoly profits is to be first.
As for your second paragraph, it was so filled with different statements that it would take a long time to respond to them all. However, let me cover a couple…
…if a company has a bunch of patents and they get sued, it won’t ruin them because as a monopolist they have more money to withstand being sued and the destruction of their reputation does not mean that people will go to competitors.
I sincerely think you believe this, even though it has been proven untrue time and time again. Let us see how many pharmaceutical companies with patents have been driven into bankruptcy, with only a little searching…
-Leiner Health – 3 Patents
-Women First Healthcare, Inc. – 1 Patent
-AtheroGenics – 24 Patents
-Miza Corporation – 1 Patent
-A.H. Robins – 216 Patents
Let us go a step further. Who has been putting out earnings warning and downsizing by thousands of people? Try Eli Lily and Pfizer. Having patents, even lots of patents, means nothing. Big pharm will go bankrupt just as fast as any other company, possibly faster as patents continue to expire faster than they are replaced. Furthermore, since reputation is critical, these companies have seen millions of people flee to competitors when problems with drugs like Vioxx happen.
One thing that way too many people forget is that for the VAST MAJORITY of drugs, there are competitive alternatives. True, there are a few drugs with no competitive alternative, but with the exception of those few, there are typically several options, and frequently dozens of options.
Having a patent does not protect you from anything, as history has proven time and again.
Justifications for Banning
How many times do I have to spell this out for you?
Simple…
BEFORE the patent expired, the EXTENT of side effects was NOT known.
AFTER the patent expired, it required a DECADE of TESTING to realize the EXTENT of the side effects.
Coupled with the realization of the extent of the side effects was spreading LSD usage in the mid to late 1960’s. Given that there was no known use for LSD, it was banned. Whether there was a patent or not is irrelevant, UNLESS you can CONCLUSIVELY SHOW by a PREPONDERANCE of EVIDENCE that having the patent from 1948 to 1953 caused the banning of the drug in 1967 (good luck with that).
Floating comments...
Since you did not do a “reply to this comment,” your comment is just floating in space, kind of like your logic.
Re:
Oh my God. Are you being deliberately stupid?
Let…me…say…this…slow…ly…so…you…under…stand.
L…S…D…was…banned…because…
(1) Its side effects were better understood after the studies completed between 1960 and 1965.
– The side effects were not completely understood until these studies were completed, especially the long term effect.
– The number of deaths were increasing with time because of accidents caused during dissociation. This side effect was also not expected.
(2) The drug was being increasingly abused with time.
(3) There were no known benefits to LSD.
– The corollary is that if there is a drug with no known benefits, and numerous, clearly demonstrated negative side effects, then the drug is not beneficial to society.
Using LOGIC, the CONCLUSION would be that BANNING the drug because of the CLEARLY DEMONSTRATED HARM the drug was doing to society was the right thing to do.
Re:
However, note that these effects can occur with lower, measured does, just less often. The statement that “many of the effects of LSD are only at high doses” may be true, but the negative effects, dissociation, flashbacks, and psychosis, were shown to occur at lower doses, though less frequently than with higher doses.
Taking arsenic in “low doses” will kill you eventually, but it will still kill you.
Re:
You know, you are like a broken record.
The patent is irrelevant. The drug has no known benefit, so why not ban it? If you no something has negative side effects, and it has no known usefulness, then why not ban it? The patent is meaningless and irrelevant and you have shown no evidence otherwise.
Re:
So you are paranoid about mainstream media too. No shock there.
I do not want you censored, I want you to make sense, which you do not.
Disagreements
I am fine with you disagreeing, but it would be nice if you could present EVIDENCE.
Re:
I never said LSD was toxic. However, neither did I ever say LSD was safe. There are an array of estimates of deaths due to LSD, from dozens to thousands. The problem is that the deaths were often classified as an accident or suicide and testing for LSD was not performed.
Lost
Oh, you are quite lost. You have stumbled on a web site with intelligent people.
Lobbying
Wrong…big pharm is not the biggest lobbyists…
Here are the top 10:
(1) AT&T
(2) American Federation of State, County & Mun Employees
(3) National Association of Realtors
(4) Goldman Sachs
(5) American Association for Justice
(6) International Brotherhood of Electrical Workers
(7) National Education Association
(8) Laborers Union
(9) Service Employees International Union
(10) Carpenters & Joiners Union
Okay, just where is the first pharm lobbyist at?
(57) Pfizer
(77) GlaxoSmithKline
(85) Eli Lilly
(97) Bristol-Myers Squibb
If you add all these contributions together they are less than the #1 and #2 contributors, INDIVIDUALLY.
Who are the big lobbyists?
Unions are HUGE. Unions as a group are about 8 times bigger than pharm as a group. Tobacco is also huge, as are financial companies. Both are bigger as a group and individually than pharm. Indeed, pharm as a group may not even be in the top 10.
LSD Not Much Worse...
You said that you would argue that LSD isn’t necessarily much worse than other unbanned drugs.
You might be correct, and you might not. I wonder how many people have died from aspirin? Some researchers believe that several thousand may have died because of the side effects of LSD, all in a period of a few years. I wonder how many people died from aspirin in that time? You make a statement for which I am hard pressed to find evidence either for or against, which means it is a strawman argument that has no meaning.
Lobbying
No idea where you’re getting that data from, but way to skew it by using individual companies instead of industries, which makes it come out like this (opensecrets.org)
Client Total
1 Finance, Insurance & Real Estate $2,558,205,882
2 Health $2,298,865,053
3 Misc Business $2,257,719,539
4 Communications/Electronics $2,092,700,759
5 Energy & Natural Resources $1,670,116,451
6 Transportation $1,358,911,163
7 Other $1,252,273,819
8 Ideological/Single-Issue $848,747,426
9 Agribusiness $819,757,771
10 Defense $668,009,653
11 Labor $265,459,714
12 Construction $264,698,101
13 Lawyers & Lobbyists $188,142,079
Lobbying
Small detail about your numbers. Betta’s comment was about PHARMACEUTICAL companies, not HEALTH companies. Since the American Medical Association is the second largest contributor, it is no wonder that “health” as a group would be number 2.
Incidentally, I also got my numbers from opensecrets.com, but I was focused on pharmaceutical companies, not health companies. There is a huge difference.
Re:
No one said that every problem is caused by patents, just that patents cause problems. There is a difference. You’re intentionally building a strawman, which merely exposes your dishonesty.
Re:
“You equate patents to communism?”
That is not what was said.
“If anything, patents are anti-communism.”
This is a lie.
“However, you have yet to prove any assertion you have made.”
Another lie.
Re:
“You have yet to explain why a patent would cause a firm to skew data.”
No, you simply ignore the explanation.
“- The invention must be novel (i.e., an innovation).”
You seem to ignore the evidence as well. The USPTO thinks that anything that hasn’t already been patented is subject to patents. Techdirt has given many examples of bad patents but I bet you can’t provide examples of good patents that have helped innovation.
“- The invention must be explained.”
Patents tend to be very general and hence tend to be useless.
“- There must be a figure unless the invention does not avail itself of being shown in a figure.”
So?
“Note from my list that there is no requirement for the invention to even WORK (however, if it does not work and the patent is shown to lead to a non-working product, it is subject to being invalidated).”
The overwhelming majority of patents do not make it to product yet how often do you find patents becoming invalidated?
“So, I will ask (for the what, fifth, sixth, seventh time?) again, what evidence do you have that patents lead companies to skew data? What about patents causes companies to skew data. Explain. Support. Use logic. Your opinions are fun, but they are not support or logic.”
More lies.
Re:
“The incentive for lawsuits DOES exist with or without patents. However, when evaluating risks, with the elimination of patents suddenly the need for speed is weighted greater than it was previously, and suddenly the amount of risk a company will take may increase when the only option to obtain monopoly profits is to be first.”
Evidence please.